FDA.reportPublic FDA data

DMT SUIK

Product NDC
80425-0556
Requested package NDC
80425-0556-1
11-digit product format
804250556
Labeler code
80425
Product ID
80425-0556_43045630-8bf9-59ae-e063-6294a90a2ebe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone Sodium Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Advanced Rx of Tennessee, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-11-07
Substance
DEXAMETHASONE SODIUM PHOSPHATE
Active strength
10 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DMT SUIK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE SODIUM PHOSPHATE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AI9376Y64PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43045630-8bf8-59ae-e063-6294a90a2ebeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0556-1DMT SUIK1 in 1 CARTONINJECTION, SOLUTION11
80425-0556-1DMT SUIK1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0556-1EA - Each80425-0556600846ad-f32e-4119-8b74-1fd1d6a4c48c12025-12-16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DMT SUIKDEXAMETHASONE SODIUM PHOSPHATEAdvanced Rx of Tennessee, LLC43045630-8bf8-59ae-e063-6294a90a2ebe2025-11-07Warnings, Adverse reactionsExact identifier
ndc (package): 80425-0556-1
ndc (product): 80425-0556
ndc11 (package): 80425055601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0556-1804250556011 VIAL, SINGLE-DOSE in 1 CARTON (80425-0556-1) / 1 mL in 1 VIAL, SINGLE-DOSE2025-11-07NoNoCurrent